Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01166659
First received: July 14, 2010
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

This study is to evaluate the safety and effectiveness of CyPass implantation for lowering intraocular pressure in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy.


Condition Intervention
Primary Open Angle Glaucoma (POAG)
Device: CyPass Micro-Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Transcend Medical, Inc.:

Primary Outcome Measures:
  • Intraocular pressure (IOP) reduction [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of target intraocular pressure (IOP) with and without use of ocular hypotensive medication [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Ocular hypotensive medication use [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to direct aqueous fluid from the front of the eye into the back of the eye. The CyPass Micro-Stent is surgically implanted into the supraciliary space of the eye through a small corneal incision.
Device: CyPass Micro-Stent

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of POAG
  • Medicated IOP ≥ 21 and ≤ 35 mmHg
  • Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria:

  • Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
  • Use of oral hypotensive medication treatment for glaucoma
  • Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
  • Clinically significant ocular pathology other than POAG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166659

Locations
Austria
University Eye Clinic
Salzburg, Austria
Bulgaria
Specialized Hospital for Active Treatment of Ophthalmologic Diseases
Sofia, Bulgaria
Germany
Schlosspark-Klinik, Department of Ophthalmology
Berlin, Germany
Augenklinik Cham
Cham, Germany
Klinik fur Augenheilkunde, Campus Lubeck
Lubeck, Germany
Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum
Neubrandenburg, Germany
Spain
Institut Catala de Retina
Barcelona, Spain
San Carlos Clinical Hospital
Madrid, Spain
Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH Transcend Medical, Inc.
  More Information

No publications provided

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01166659     History of Changes
Other Study ID Numbers: TMI-10-03
Study First Received: July 14, 2010
Last Updated: August 27, 2014
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission
Bulgaria: Ministry of Health

Keywords provided by Transcend Medical, Inc.:
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 14, 2014